MLB Takes Another Swing at Complying with GINA

In 2008 Congress passed the Genetic Information Nondiscrimination Act (GINA). Although GINA is arguably “the first civil rights bill of the 21st century,” we have consistently reminded Genomics Law Report readers that passing GINA into law was only the first step.

As is the case with any piece of new legislation, even after a law is passed, considerable work remains to implement that law in practice. GINA is no different. Congress provided a basic framework designed to eliminate genetic discrimination, but many of the details of the law were left to regulatory agencies.

Two and a half years after GINA’s passage, the first part of that process is still underway. Last month the EEOC issued final rules and regulations implementing Title II of Gina, which applies to employers. (Final regulations for Title I of GINA, which applies to health insurers, have yet to be issued.) With the long-awaited arrival of the EEOC’s final regulations, the next step is to begin to apply those regulations.

MLB’s Genetic Testing Program. In July of 2009 The New York Times reported that Major League Baseball (MLB) had begun using genetic testing to verify the age and identity of Latin American baseball prospects. We analyzed MLB’s genetic testing program and the potential legal concerns raised by GINA in a pair of posts: “MLB Meets GINA” and “MLB’s Genetic Testing Program at the Plate Again.”

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Filed under General Interest, Genetic Testing/Screening, Genomic Policymaking, Genomics & Society, GINA, Industry News, Legal & Regulatory, Pending Regulation, Privacy

Prometheus Unbound—Again

The latest news from the field of biotechnology patents is in: the Federal Circuit has handed down its opinion (again) in Prometheus v. Mayo (pdf), the closely watched diagnostic method case. The verdict is the same as before: Prometheus’s patents satisfy the § 101 test for patentable subject matter.

On Monday, we wrote about the Federal Circuit’s first post-Bilski method patent decision: Research Corporation Technology v. Microsoft. In analyzing RCT we argued that it was “a good bet that the Prometheus and Myriad patents, and others like them, will survive § 101.” That bet paid off today in Prometheus and, based on the signals the Federal Circuit sent in that opinion, we think it is increasingly likely to pay off again in Myriad in the form of at least a partial reversal (more on this below).

Applying Bilski means Business as Usual. Way back in June, when the Supreme Court decided Bilski, it not only failed to provide lower courts (including the Federal Circuit) with meaningful guidance for biotechnology method patents, it arguably failed to provide meaningful guidance about anything at all. Despite predictions that Bilski might fundamentally reshape the patent landscape, the Court’s fractured opinions produced little in the way of binding law. The clearest statement from the Court was that the machine-or-transformation test for method patentability, which the Federal Circuit had previously deemed an exclusive test, was in fact only a “useful and important tool.” (Other useful and important tools were not, however, enumerated.)

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Filed under General Interest, Genetic Testing/Screening, Genomic Policymaking, Genomics & Society, Industry News, Legal & Regulatory, Myriad Gene Patent Litigation, Patents & IP, Pending Litigation

A Hint About Where the Federal Circuit Is Going with Method Patents?

GLR readers will recall that just last summer the Supreme Court passed-up a major opportunity to clarify the status of method or process patents. The patentability of business methods, computer-implemented processes, and diagnostic and other medical methods has long been both controversial and uncertain. In Bilski v. Kappos, the Court confronted a method for hedging against fluctuations in commodities prices. All nine justices thought the method was too abstract to comprise patentable subject matter as defined in section 101 of the Patent Act, but they couldn’t agree on why. The five-member majority held that the machine-or-transformation test (which states that the method must be tied to a particular machine or change something into a different state) propounded by the Federal Circuit in its initial Bilski decision could not be the exclusive test for patentability, but it failed to come up with a test of its own.

The day after issuing its decision in Bilski, the Supreme Court dealt, temporarily, with another closely watched case, Prometheus v. Mayo. In Prometheus, the Federal Circuit used Bilski’s machine-or-transformation test to uphold a method for administering a drug, measuring its level in the body, and then adjusting the dosage. The Supreme Court granted certiorari in Prometheus, as well as in a similar biotechnology method case (Classen Immunotherapies v. Biogen IDEC), and then immediately vacated both decisions and remanded the cases to the Federal Circuit for reconsideration in light of Bilski. Neither of those decisions have yet been issued by the Federal Circuit.

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Filed under Legal & Regulatory, Myriad Gene Patent Litigation, Patents & IP, Pending Litigation

Surreptitious Genetic Testing: WikiLeaks Highlights Gap in Genetic Privacy Law

The top news story the past two weeks: the release of hundreds of thousands of confidential American diplomatic cables by WikiLeaks. While dissecting diplomatic maneuvering is not a traditional area of expertise for the Genomics Law Report, a pair of cables did catch our eye.

The first is primarily a curiosity: the allegation that Chinese authorities are spying on deCode Genetics, Iceland’s most prominent genetic research company and provider of the direct-to-consumer genetic testing service, deCODEme. Nobody seems to know exactly what China is looking to gain by clandestinely exploring Iceland’s genetic genealogy. You are welcome to speculate in the comments.

The second raises broader issues: the revelation that the State Department’s ongoing human intelligence collection directives include requests for “biometric information” on key world leaders, including United Nations arms inspectors, the Director General of the World Health Organization (WHO) and key advisors and aides to United Nations Secretary General Ban Ki-moon. A separate cable detailing intelligence collection priorities in Africa’s Great Lakes region clarifies that “biometric information” includes “health [data]…fingerprints, facial images, DNA, and iris scans.”

Not disclosed in the WikiLeaked cables: why the State Department wants the biometric data or whether any have been successfully obtained.

Surreptitious Testing: An Overview. The cables are, however, a reminder that the law surrounding the surreptitious collection and testing of biometric data, including DNA, remains extremely murky.

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Filed under Biobanking, Direct-to-Consumer Services, General Interest, Genetic Testing/Screening, Genomic Policymaking, Genomics & Society, GINA, Industry News, Informed Consent, International Developments, Legal & Regulatory, Pending Regulation, Privacy

Twitter Roundup

With so many developments at the intersection of genomics and the law, there are often a variety of interesting stories that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. Here is a recap of what I was Tweeting recently @genomicslawyer:

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